OC NEW Advisory Committee Nominations 21 APR 2017

FOOD AND DRUG ADMINISTRATION
Advisory Committee Membership Nominations
OMB Control No. 0910-NEW
SUPPORTING STATEMENT

A. Justification
1. Circumstances Making the Collection of Information Necessary
The Food and Drug Administration’s (“FDA”) Advisory Committees are established to advise
or make recommendations on matters of public health that come before the agency. The
Federal Advisory Committee Act (5 U.S.C. App. 2 § 3, P.L. 92-463) (“FACA”) defines what
constitutes an “advisory committee” under the Act and provides general procedures to follow
for the operation of advisory committees. In addition, FACA is designed to assure that the
Congress and the public are kept informed with respect to the purpose, membership, and
activities of advisory committees. FDA regulations at 21 CFR Part 14 also establish
procedures applicable to its advisory committees.
FACA does not specify the manner in which advisory committee members and staff must be
appointed. (See generally 5 U.S.C. App. 2 . See also, 41 CFR §§ 102-3.105, 102-3.130(a)).
FDA’s regulations, however, specify that the Commissioner “will publish one or more notices
in the Federal Register each year requesting nominations for voting members of all existing
standing advisory committees.” (21 CFR § 14.82(a)). Nominations must specify the
committee for which the nominee is recommended, include a complete CV, state that the
nominee is aware of the nomination and willing to serve, and state that the nominee appears to
have no conflict of interest that would preclude membership. (21 CFR § 14.82(c)). In an effort
to promote transparency, consistent with FDA and General Services Administration (“GSA”)
policy (See, GSA regulations encouraging agencies to “practice openness” and suggesting that
“agencies may wish to explore the use of the Internet to post advisory committee information
…” 41 CFR § 102-3.95(d)), and pursuant to a settlement agreement in the case Public Citizen
Foundation, Inc. v. Food & Drug Administration, et al., No. 16-cv-781 (D.D.C.), FDA is also
seeking consent from nominees for FDA to publicly post their CVs in the event they are
selected to serve on an FDA advisory committee.
Accordingly, FDA is requesting approval for the information collection provisions associated
with its Advisory Committee Membership Nomination process.
2. Purpose and Use of the Information Collection
FDA has a total of 50 advisory committees and panels and convenes, on average, 60 advisory
committee meetings per year. There are, on average, 9 committee members on each committee
or panel. In addition to its standing members, FDA invites additional expert consultants to
participate in committee meetings as needed. To ensure that its advisory committees are

staffed with the necessary members and consultants, FDA must establish a repository of
candidates that have the necessary qualifications to provide technical and scientific advice for a
wide range of meeting topics.
FDA chooses to select advisory committee members through a nomination process. A person
can self-nominate or be nominated by another individual. In order to identify and select
qualified individuals to serve on its advisory committees, FDA has established an online portal,
the “FDA Advisory Committee Membership Application”, to accept nominations of potential
advisory committee members. The nominations are collected in order to determine if the
nominee has the expertise in the subject matter with which the committee is concerned, and if
the nominee has diverse professional education, training, and experience so that the committee
will reflect a balanced composition of sufficient scientific expertise to handle the problems that
come before it (21 CFR § 14.80(b)(1)(i)). In the case of Industry and Consumer
Representatives, information is collected to assess the candidate's ability to represent all
interested persons within the class which the member is selected to represent (21 CFR §
14.86(c)). To further the agency's goals of promoting transparency regarding the advisory
committee process, FDA will also require that nominees submit a consent form authorizing
FDA to publicly post to FDA's Web site the CV submitted as part of their nomination
materials, in the event that the nominee is selected to serve on an advisory committee.
FDA believes that publishing the entire CV of new advisory committee members without
redaction will increase public confidence that FDA’s review of advisory committee
membership nominations and the subsequent selection process has been conducted thoroughly
and objectively, without regard to politics or relationships with third parties. Applying this
policy across all FDA advisory committees further supports FDA’s goal of maintaining science
as the primary determinant in agency decision making. FDA does not believe that requiring
prospective members to consent to the posting of their CVs, in the event they are selected for
membership, will have a negative impact on the number of nominations received. Advisory
committee members are compensated by FDA for their service, and the requirement to consent
to publication of their CVs imposes only a minimal burden. Such posting will provide an
additional level of accountability for officials that make decisions of great significance to FDA,
industry, and the public at large.
Finally, under of the Federal Food, Drug, and Cosmetic Act (“FD&C Act” at 21 U.S.C. § 379d[1]
1(e)) FDA is required to annually report to Congress on, inter alia, its advisory committee
vacancies, the number of persons nominated for membership in FDA’s advisory committees,
the number of nominees who are selected to serve on FDA’s advisory committees, and the
number of nominees who were asked to serve, but unable to participate due to a financial
conflict of interest. The collection of information through the application portal helps FDA to
meet this reporting requirement.
[1] 21 U.S.C. § 379d-1(e). This annual report requirement was added by the Food and Drug
Administration Amendments Act of 2007 (FDAAA), signed into law on September 27, 2007, and
amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), effective October
1, 2012. Title VII of FDAAA added new conflict of interest provisions applicable to FDA advisory
committees, effective October 1, 2007.

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3. Use of Improved Information Technology and Burden Reduction
The information collection provides for electronic submissions. To minimize burden on
respondents, FDA has established an applicant portal on its website at:
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm through which
submissions are made to the agency. To facilitate reporting we have established a standardized
format for information data elements and a separate field for uploading necessary
documentation. Finally, updated CVs are collected annually from industry representatives
currently serving on FDA’s advisory committees through e-communications.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
The information collection does not impose a significant burden on small entities. Respondents
to the collection are private individuals who nominate other individuals to serve on FDA
advisory committees, or are private individuals submitting self-nominations to serve on FDA
advisory committees.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with existing laws and regulations. Under 21
U.S.C.§ 379d-1(b)(1)(C), FDA must solicit referrals of potential new advisory committee
members at least every 180 days. Accordingly, under agency regulations, the Commissioner of
Food and Drugs will publish “one or more notices in the Federal Register each year requesting
nominations for voting members of all existing standing advisory committees.” (21 CFR §
14.82(a)). Similarly, and except for committees established by statute, the Commissioner “will
issue a Federal Register notice certifying that the establishment or renewal [of an advisory
committee] is in the public interest and stating the structure, function, and purposes of the
committee and, if it is a standing advisory committee, shall amend §14.100 to add it to the list
of standing advisory committees.” (21 CFR § 14.40.)
7. Special Circumstances Relating to the Guidelines in 5 CFR § 1320.5
There are no special circumstances related to the information collection.

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8. Comments in Response to the Proposed Rule and Efforts to Consult Outside the Agency
In the Federal Register of February 6, 2017 (82 FR 9383) FDA published a notice requesting
public comment on the proposed information collection. One comment was received in support
of the information collection, and it recommended no changes to the agency’s burden estimate.
On our own initiative, however, we have revised the estimate provided in our 60 day notice to
reflect an increase of 23.5 burden hours and 94 responses. While we believe our original
burden estimate accurately reflects the time burden associated with providing the specific data
elements, we have increased the number of respondents to the collection to include Industry
Representative members of FDA advisory committees. These burden estimates are discussed
in more detail under Question 12a, below.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
While FDA makes no promise of confidentiality, information provided by respondents is
covered by two applicable System of Record Notifications (SORNs):


SORN 09-90-0080 – The Secretary's Advisory Committee Candidate Files,
HHS/OS/ES: this covers individuals who are being considered for membership on
advisory committees within the jurisdiction of the Department of Health and Human
Services; and



SORN 09-90-0059 – Federal Advisory Committee Membership Files, HHS/OS/ASPER:
this covers individuals who have been or are presently members of, or are being
considered for membership on, advisory committees within the jurisdiction of the
Department of Health and Human Services. Additionally this system of records
contains information about members of the public who have requested that they receive
various publications through the inclusion of their names and addresses on various
mailing lists.

Notice of the applicability of the SORNs and circumstances under which information submitted
to the portal may be released by the agency is provided in the Advisory Committee Application
portal. The notification includes a statement that FDA will routinely post the CVs of nominees
selected to serve on its advisory committees.
11. Justification for Sensitive Questions
There are no questions of a sensitive nature.

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12. Estimates of Annualized Hour Burden and Costs
12a. Annualized Hour Burden Estimates
Based on a review of data, we received 638 nominations for membership to FDA
advisory committees in Fiscal Year (FY) 2011; we received 603 nominations in FY 2012; we
received 622 in FY 2013; we received 545 in FY 2014; and we received 505 nominations in FY
2015. By averaging the number of nominations received annually over the past five years, we
estimate there are approximately 583 respondents to the information collection. We estimate it
takes respondents 15 minutes to complete an initial application, where accompanying
documentation is already available or has been prepared in advance by respondents.
Multiplying 15 minutes (0.25) by the number of respondents to the information collection (583)
equals 145.75 annual burden hours.
We have also included a burden estimate for members who currently serve on FDA
advisory committees who are not Special Government and Regular Government Employees
and who must submit an updated CV and an executed/completed consent form annually.
Currently there are 64 authorized positions for these Representative members, mostly Industry
Representatives. While some positions are vacant, we anticipate the positions will be filled
during the year. The request for the updated CV and consent will be made through email
communications by the Designated Federal Officer of the committee. The burden to the
respondent is anticipated to be the same as the burden for new nominations. We estimate each
response will require 15 minutes (0.25) for a total of 16 annual hours.
We therefore estimate the burden of the collection of information as follows:
Table 1 – Estimated Annual Reporting Burden1
21 CFR Part 14;
Subpart E--Members
of Advisory
Committees
Advisory Committee
Membership
Nominations
Representative
Member Submission
of Updated
Information
TOTAL
1

No. of
Respondents

No of Responses
per Respondent

Total
Annual
Responses

583

1

583

64

1

64

Average
Burden
per
Response
0.25
(15
minutes)
0.25
(15
minutes)

647

There are no capital or operating and maintenance costs associated with the information collection.

12b. Annualized Cost Burden Estimates
We estimate no capital costs to respondents for the collection of information.

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Total
Hours

145.75

16.0

161.75

13. Estimates of Other Total Annual Cost Burden to Respondents and Recordkeepers
There are no start-up, operating, or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
FDA currently devotes approximately 250 hours annually to the review and processing of
nominations received through its Advisory Committee Application portal, including advising
nominees of their selection. Using an hourly wage rate for the Washington DC/Metropolitan
area at the GS-13/1 level ($40), we calculate the cost to the Federal government to be
approximately $10,000 annually.
15. Explanation for Program Changes or Adjustments
This is a new information collection request.
16. Plans for Tabulation and Publication and Project Time Schedule
The nomination packages collected pursuant to this ICR will be used by FDA to select
appropriately qualified individuals to serve on its advisory committees. In an effort to promote
transparency, consistent with FDA and GSA policy (see, GSA regulations encouraging
agencies to “practice openness” and suggesting that “agencies may wish to explore the use of
the Internet to post advisory committee information …” 41 CFR § 102-3.95(d)), and pursuant
to a settlement agreement in the case Public Citizen Foundation, Inc. v. Food & Drug
Administration, et al., No. 16-cv-781 (D.D.C.), FDA plans to post on FDA’s website, the CVs
of nominees that are selected to serve on FDA’s advisory committees at the time of their
selection. FDA does not plan to make public other application materials of advisory committee
members, or the CVs of nominees who are not selected to serve on FDA advisory committees.
Consistent with notice published in the Federal Register of February 6, 2017 (82 FR 9382),
FDA has already begun soliciting updated CVs and consent forms from currently serving
advisory committee members and publicly posting those CVs on FDA’s website. While such
information collection from Regular and Special Government Employees is exempt from OMB
review under the PRA, FDA’s currently serving advisory committee members have been
cooperating with implementation of this new policy. Pursuant to this policy therefore, CVs of
currently-serving advisory committee members will be posted on a rolling basis as members
update their information with the agency.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB Expiration date is appropriate.

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18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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